The Staying Safe Intervention

NCT03418636 | Unknown DMC

• 1 other identifier: 652
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief Summary

The growing population of young people who inject drugs (PWID) is at extremely high risk for HCV infection through the use of contaminated injection equipment, yet, to date, no behavioral intervention has been sufficiently potent to produce significant reductions in HCV incidence among PWID. To address this critical public health need, our team developed Staying Safe (Ssafe), an innovative, strengths-based, socio-behavioral HCV prevention intervention found in preliminary research to be highly acceptable and feasible, with strong indications of efficacy. The proposed randomized, controlled trial will assess the effectiveness of the Ssafe intervention in reducing both injection-related HCV/HIV risk behavior and HCV incidence among young adults (ages 18-29) who inject opioids (heroin and/or prescription opioids).

Conditions

Hepatitis C; Opioid Use

Keywords

People who inject drugs; Hepatitis C prevention; Young adults; Behavioral interventions

Outcome Measures

Primary Outcomes (6)

• Injection risk behavior: Syringe-sharing

  number of times receptively shared syringes

  3 months

• Injection risk behavior: Syringe-sharing partners

  number of people receptively shared syringes with

  3 months

• Injection risk behavior: Secondary injection equipment-sharing

  number of times receptively shared secondary injection equipment (including cookers, cottons, water and water containers combined)

  3 months

• Injection risk behavior: Secondary injection equipment-sharing partners

  number of people receptively shared secondary injection equipment with (including cookers, cottons, water and water containers combined)

  3 months

• Injection risk behavior: Backloading

  number of times backloaded

  3 months

• Injection risk behavior: Backloading partners

  number of people backloaded with

  3 months

Secondary Outcomes (4)

• Hepatitis C incidence

  12 months

• Overdose events

  3 months

• Injection frequency

  30 days

• Injection-related complications

  3 months

Other Outcomes (4)

• Injection network size

  3 months

• Motivation/Self-efficacy to inject safely and manage opioid intake

  3 months

• OUD treatment participation

  3 months

Study Arms (2)

Staying Safe (Ssafe)

EXPERIMENTAL

Ssafe is delivered in a small group format (consisting of approximately 10-12 participants) by a trained facilitator over 4 2.5-hour sessions (10 hours total). To help promote the maintenance of risk reduction over the trial's 12-month follow-up period, Ssafe participants will be provided with a novel interactive, smartphone-delivered "booster" application based on core Ssafe principles and risk reduction strategies.

Behavioral: Staying Safe (Ssafe)

Healthy Living

ACTIVE COMPARATOR

Healthy Living is a time- and attention-matched control intervention of equivalent session structure and duration as Ssafe (4 2.5-hour sessions; 10 hours total), also delivered in a small group format (10-12 participants). Healthy Living participants will be provided with a publicly available, sleep hygiene-focused smartphone app to promote healthy sleep habits over the trial's follow-up period.

Behavioral: Healthy Living

Interventions

Staying Safe (Ssafe) BEHAVIORAL

Staying Safe motivates and teaches young people who inject drugs (PWID) planning skills and drug use management strategies to enable long-term risk avoidance and the implementation of healthy protective behaviors. Content is presented through guided discussions and role playing exercises, and relies heavily on interactive participation by group members to foster peer-based learning and social reinforcement processes.

Staying Safe (Ssafe)

Healthy Living BEHAVIORAL

The content of the Healthy Living intervention is based on the DHHS' Eat Healthy, Be Active Community Workshop curriculum, supplemented with basic sleep hygiene education. Science-based dietary and light physical activity guidelines are demonstrated and promoted to help participants develop and maintain a healthy lifestyle.

Healthy Living

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Hepatitis C antibody-negative
• HIV antibody-negative
• Have injected drugs 4 or more times in the past 30 days
• Current opioid use (verified by rapid urine screen)
• Speak English
• Willing to participate in assigned intervention

Sponsors & Collaborators

• National Development and Research Institutes, Inc.: lead

Study Sites (1)

Staying Safe Study 235 Eldridge Street

New York, New York, 10002, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Honoria Guarino, PhD

CONTACT

212-845-4540; guarino@ndri.org

Ramona Almenana, MPA

CONTACT

almenana@ndri.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 1, 2018
• Study Start: January 31, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

US (1)